Electronic Cigarettes: Unregulated and Untested

The U.S. Appeals court in Washington D.C. ruled last Tuesday that the Food and Drug Administration lacks the authority to regulate electronic cigarettes as either a drug or a device, leaving the FDA with only as much regulatory power as it wields over tobacco products. The ruling came just days after researchers in California published a study detailing safety and marketing concerns with every brand of e-cigarettes.

E-cigarettes are designed to look like tobacco cigarettes, but they deliver hits of nicotine vapor. When the smoker draws on the mouthpiece, air passes through and activates a battery-powered atomizer that vaporizes liquid nicotine from a disposable cartridge. Manufacturers market them, in part, as a safer alternative to smoking (one company calls its product the "Safe Cig"), and as an aid to quitting.

These claims, however, have never been established to the satisfaction of the FDA. And in April, the agency moved to ban imports of e-cigarettes into the country until companies gained approval for the devices, a process that would require rigorous proof of their safety and efficacy. Nicotine patches and nicotine gum were held to similar standards before eventually gaining approval.

In turn, Sottera Inc., a company that makes and imports e-cigarettes under the name NJOY sued the FDA, claiming that the gadget should be classified as a tobacco product, although it contains no tobacco.

Just days before the ruling, a group of researchers in California published a study calling into question the safety of e-cigarettes. The group claims that the toxicity level of vaporized nicotine is virtually unstudied. They also found various design flaws with the devices themselves, including leaky cartridges and insufficient labeling. Another study in January warned that e-cigarettes may not be any healthier than tobacco cigarettes.

The debate has attracted passionate opinions in the blogosphere. For now, at least, the courts have resolved the issue in favor of e-smokers.

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